Stimulates the metabolism of body fat, to help patients lose an average of 6.2 pounds over 12 weeks.
An Australian-owned obesity drug, developed by Melbourne-based biotechnology company Metabolic Pharmaceuticals Limited, is set to enter final human trials next year after successfully completing a Phase 2b human trial which proved that the drug induces weight loss and is very well tolerated with no evidence of the side effects commonly experienced with existing obesity drugs.
The drug, which stimulates the metabolism of body fat, is the first of its kind in the world. All other obesity drugs artificially reduce appetite or food absorption.
The drug – codenamed AOD9604 – was taken orally once daily by 300 obese patients at five trial sites over a 12-week period. Six doses were used – 0 mg (placebo), 1mg, 5 mg, 10 mg, 20 mg and 30 mg.
The group receiving the 1mg dose lost the most weight, averaging a weight loss over the 12 weeks of 2.8 kilograms, more than triple the weight lost by those on placebo, who lost an average of 0.8 kilograms. The rate of weight loss was maintained throughout the treatment period, an encouraging trend for expectations of longer-term dosing.
The weight lost by the 1mg group was slightly more than that achieved by the world’s largest selling prescription obesity medication in similar trials over the same period, without its troublesome side effects. The trial results also demonstrated a small but consistent improvement in cholesterol profiles, and a reduction in the number of patients with impaired glucose tolerance.
AOD9604 is based on a small part of the human growth hormone molecule. This hormone, which occurs naturally in the body and which stimulates fat metabolism, is suppressed in obese people.
Prof. Gary Wittert, Adelaide-based Principal Investigator on the study, said: “As the world’s first drug with a metabolic mechanism of action AOD9604 could occupy a unique position among the options available to doctors for the management of obesity.
Prof. Louis J Aronne MD, President of the North American Association for the Study of Obesity and a member of Metabolic’s Clinical Advisory Panel, said: "This is an exciting new approach to a problem which has defied easy solutions. We will need many different treatments if we are going to manage obesity successfully, in much the same way we have many treatments available for diabetes and hypertension". Metabolic’s AOD9604 is a synthesized version of that part of the human growth hormone molecule
Metabolic Pharmaceuticals Limited http://www.metabolic.com.au